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About Diane 35®

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Description

Diane 35® is combined oral contraceptive, manufactured by Bayer. The medication contains two active compounds: Cyproterone Acetate and Ethinyl Estradiol.

Cyproterone Acetate (CPA) is a derivative of progestin (synthetic progestogen) and is also an antiandrogen. Ethinyl Estradiol is a synthetic estrogen (female sex hormone). Like naturally occurring in the body hormone estrogen, Ethinyl Estradiol regulates and maintains menstrual cycle.

Mechanism of action: Cyproterone Acetate and Ethinyl Estradiol in Diane 35® tablets work in conjunction and provide effective contraception by inhibiting the secretion of gonadotropins (follicle stimulating hormone, FSH and luteinizing hormone, LH). Ethinyl Estradiol stops ovaries from releasing an egg, while Cyproterone does not allow sperm fertilize any egg that may have already released, stops a fertilized egg from implanting itself to womb lining.

Other indications for using Diane 35®:

Polycystic ovary syndrome (PCOS) - endocrine and metabolic disorders in women, characterized by ovulatory dysfunction, followed by such symptoms as oligomenorrhea or amenorrhea, either clinical or biochemical hyperandrogenism. Diane 35® serves multiple roles in the treatment of PCOS from regularizing the cycle to reducing acne, hirsutism and providing contraception to a select group of patients of PCOS who so desire it.

Hyperandrogenic disorders: Cyproterone Acetate decreases androgen production through an inhibition of 5α reductase in the skin and a subsequent decrease in dihydrotestosterone levels. I.e., Cyproterone blocks the male hormone testosterone's receptors on end organ sites such as the skin, hair follicles and sebaceous glands. This enhances the ability of Diane 35® to treat hyper or excessive androgenic disorders by a reduction in sebaceous secretions, excessive hair growth and acne.

Cancer Prevention: endometrial cancer (lining of the uterus or womb) and Ovarian cancer are prevented by prolonged usage of Diane 35® pills with benefits of cancer free periods lasting many years after stopping treatment.

Diane 35® is also used in women with benign disorders like pelvic infections and pain, benign ovarian cysts, benign fibrocystic breast disease.

The goal of Diane 35® is to provide a contraceptive action as well as anti-androgenic effect to treat the severe symptoms of androgenization in women.

Diane 35® doesn't protect you and your partner from sexually transmitted diseases (HIV and the others).

Dosage

Diane 35® should be taken orally whole, with a full glass of water once daily at the same time each day.

Diane 35® contains 21 tablets.

Take one tablet a day for 21 days and then have 7 days off (time for periods).

Take Diane 35® continually to ensure effective contraception.

If you have vomiting or diarrhea within 3-4 hours of taking a tablet, this is the same as missing a pill and you should take other contraceptive precautions for the next 7 days.

Take Diane 35® as long as your doctor recommends.

While taking Diane 35®, you should not use an additional hormonal contraceptive.

For the treatment of PCOS and hyperandrogenism (hirsutism, acne, seborrhea, oily skin, hidradenitis suppurativa):

- take Diane 35® for at least 3-4 months to achieve the positive results.

You should take Diane 35® for as long as your doctor recommends.

Missing a dose

If you have vomiting or diarrhea within 3-4 hours of taking a tablet, this is the same as missing a pill and you should take other contraceptive precautions for the next 7 days.

If you miss a dose and you are less than 12 hours late in taking a tablet, take it as soon as you remember and take the next one at the time of your next regularly scheduled dose. You are still protected against pregnancy.

If you miss a dose of Diane 35® and are more than 12 hours late in taking a tablet, follow these guidelines to help you decide what to do:

- week 1 - take the last tablet as soon as you remember and take the next one at the time of your next regularly scheduled dose, which may mean taking 2 tablets in one day. Use another form of birth control for at least 7 days following the missed tablets;

- week 2 - take the last tablet as soon as you remember and take the next one at the time of your next regularly scheduled dose, which may mean taking 2 tablets in one day. You are not at risk of becoming pregnant and do not need to use another form of birth control;

- week 3 - take the last tablet as soon as you remember and take the next one at the time of your next regularly scheduled dose, which may mean taking 2 tablets in one day. Take the remaining tablets then begin the next pack immediately without a break. You may not have a withdrawal bleed but you are still protected against pregnancy.

Overdose

If an overdose occurs and you are feeling unwell, you should seek emergency medical attention or contact your healthcare provider immediately.

Storage

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) and away from excess moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children.

Side effects

The most common side effects associated with Diane 35® are:

  • breast tenderness
  • breast pain
  • abdominal pain
  • nausea
  • oedema
  • headache
  • skin rash
  • itching
  • insomnia
  • depression

The most common side effects associated with Diane 35® are:

  • breast tenderness
  • breast pain
  • abdominal pain
  • nausea
  • oedema
  • headache
  • skin rash
  • itching
  • insomnia
  • depression

Less common side effects include:

  • migraine
  • fluid retention
  • altered body weight
  • altered libido

Side effects occurrence does not only depend on the medication you are taking, but also on your overall health and other factors.

Contraindications

Do not take Diane 35® if you are allergic to its components.

Do not take Diane 35® if you are using another oral contraception.

Do not take Diane 35® if you have deep venous thrombosis (blood clot), thromboembolic disorders, heart attack or stroke.

Do not take Diane 35® if you have a known or suspected hormone-dependent tumor such as breast or endometrial carcinoma.

Do not take Diane 35® if you have jaundice, severe liver disease or a history of liver disease.

Do not take Diane 35® if you have high blood pressure or diabetes with changes to the blood vessels.

Do not take Diane 35® if you are a diabetic taking antidiabetics or insulin, as the cyproterone acetate tablets may affect your glucose tolerance.

Do not take Diane 35® if you are taking antibiotics: amoxicillin (e.g., Augmentin), ampicillin (e.g., Omnipen), doxycycline (e.g., Vibramycin, Doryx), griseofulvin (e.g., Grifulvin V, Fulvicin PG, Grisactin), minocycline (e.g., Minocin), penicillin (e.g., Bicillin, Veetids, Pen-Vee K), rifampin (e.g., Rifadin), rifabutin (e.g., Mycobutin), tetracycline (e.g., Robitet, Sumycin, Achromycin).

Do not take Alesse if you are also taking St. John's Wort.

Do not take Diane 35® if you are also taking barbiturates: barbiturate (e.g., Amytal), butabarbital (e.g., Butisol), mephobarbital (e.g., Mebaral), secobarbital (e.g., Seconal) or phenobarbital (e.g., Solfoton, Luminal).

Do not take Diane 35® if you have any unexplained vaginal bleeding.

Do not take Diane 35® if you are pregnant, plan to have a baby or breastfeeding.

Diane 35® is not a method of emergency contraception.

Diane 35® doesn't protect you and your partner from sexually transmitted diseases (HIV and the others).

Keep Diane 35® away from children and don't give it to other people for using.

Q: How does Diane 35® prevent pregnancy?

A: Cyproterone Acetate and Ethinyl Estradiol in Diane 35® tablets work in conjunction and provide effective contraception by inhibiting the secretion of gonadotropins (follicle stimulating hormone, FSH and luteinizing hormone, LH). Ethinyl Estradiol stops ovaries from releasing an egg, while Cyproterone does not allow sperm fertilize any egg that may have already released, stops a fertilized egg from implanting itself to womb lining.

Q: Is Diane 35® good for acne?

A: Diane 35® effectively helps in the treatment of acne. Cyproterone Acetate decreases androgen production through an inhibition of 5α reductase in the skin and a subsequent decrease in dihydrotestosterone levels. I.e., Cyproterone blocks the male hormone testosterone's receptors on end organ sites such as the skin, hair follicles and sebaceous glands. This enhances the ability of Diane 35® to treat hyper or excessive androgenic disorders by a reduction in sebaceous secretions, excessive hair growth and acne.

Q: Is Diane 35® safe?

A: Diane 35® is safe in most women if taken as recommended.

Q: Is Diane 35® a combined contraceptive?

A: Yes, it is. Diane 35® is a combined oral contraceptive, consisting of two active components - synthetic female sex hormone Ethinyl Estradiol and anti-androgen Cyproterone Acetate.

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